Status™ COVID-19/Flu test is a lateral flow immunoassay intended for the in vitro rapid,
simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV2, influenza A and influenza B directly from anterior nasal and nasopharyngeal swab specimens obtained from individuals, who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider, within the first five days of onset of symptoms. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high, or waived complexity tests.
This test is authorized for use at the Point of Care (POC), i.e., in patient care
settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
25 Test Devices
25 Extraction Reagents in Capsules
25 Sterile Swabs
1 Positive and 1 Negative Control Swabs
1 Package insert
1 Quick Reference Instruction
Positive: Determination of a positive result is made at fifteen (15) minutes. A reddish purple Control line (C position) and a reddish purple Test line (Flu A, Flu B or CoV19 position) indicate that Influenza A, B and/or SARS-CoV-2 antigen has been detected. Lines at the A and C positions indicate the presence of Influenza type A viral antigen, lines at the B and C positions indicate the presence of Influenza type B viral antigen, and lines at the CoV19 and C positions indicate the presence of SARS-CoV-2 viral antigen in the specimen. A positive result does not rule out co-infections with other pathogens or identify any specific influenza A virus subtype.
Negative: A reddish purple Control line (C position) only, with no Test line at the A, B, CoV19 positions, indicates that Influenza A, B antigen or SARS-CoV-2 antigen has not been detected. A negative result does not exclude influenza viral or SARS-CoV-2 viral infection. Determination of negative results should not be made before 15 minutes.
Invalid: A reddish purple line should always appear at the Control line position (C
position). If a line does not form at the Control line position in 15 minutes, the test result
is invalid and the test should be repeated with a new Status™ COVID-19/Flu test device.
IMPORTANT: Please refer to package insert (instructions for use) for more comprehensive product information.
CPT Codes for COVID-19 and Flu A/B:
FLU A: 87804QW
FLU B: 87804QW-59